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Quality Engineer

  • Salary: Negotiable
  • Job type: Permanent
  • Location:
  • Sector: Engineering
  • Date posted: 01/12/2017
  • Job reference: J378286A

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Quality Engineer- NPI Projects

Job Summary

The Quality Engineer will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production process for compliance to implemented process controls for product and process projects, as well as providing backup support for quality engineers.

Accountabilities include:

  • Developing and maintaining quality world class systems related to the manufacture of guide wires while developing employee efficiencies.
  • Responsible for all quality aspects of projects and areas of support including:
  • Validations.
  • Engineering Change Order (ECO).
  • Corrective & Preventative Action (CAPA).
  • Request for Technical assistance (RTA)
  • Material Review Request (MRR).
  • Failure Mode Effect Analysis (FMEA).
  • Variation Permits (VP).
  • Responsible for the successful completion of all quality aspects of customer FARFs
  • Playing a role in the plant annual objectives.
  • Ensure continued compliance with all Regulatory Standards. This includes:
    • ISO 13485
    • FDA QSR
    • ISO 14000
    • Ensuring continued compliance with DMR
  • Develop and maintain a program ensuring only correctly validated equipment is used in production process. This will include:
    1. Participation in validation protocol development
    2. Overseeing completion of validation or validation samples
    3. Supporting the manufacturing engineering function to ensure compliance to related element of quality system.
  • Ensure the company behavioural standards are adhered to
  • Project meeting attendance as required.
  • Preparation of information for PMR and Management Review meetings.

Skills, Knowledge, & Education:

  • Ability to communicate and work with people inside and outside the department.
  • Good communicator (written and oral).
  • Ability to train and lead.
  • Ability to co-ordinate, plan and organise in a timely manner.
  • Knowledge of engineering theories and methods.
  • Good technical report writing skills.
  • Rigorous attention to detail.
  • Engineering or science Degree preferably with Quality Engineering included.
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